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Completed

NCT Number: NCT02358889

Study Evaluating Intravitreal hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

The purpose of this study is to evaluate the safety, biological activity and pharmacodynamic effect of repeated intravitreal doses of hI-con1 0.3 mg administered as monotherapy and in combination with ranibizumab 0.5 mg compared to ranibizumab 0.5 mg monotherapy in treating patients with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

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Key information

Conditions

Choroidal Neovascularization Age-Related Macular Degeneration Choroid Diseases Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females of any race at least 50 years of age
  • Active primary Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) in the study eye
  • Best Corrected Visual Acuity (BCVA) of 70 to 24 letters (worse than 20/40 up to 20/320) in the study eye

Exclusion criteria

  • Monocular patient or patient with a BCVA of 35 or fewer letters (20/200 or worse) in the better seeing eye
  • Any prior treatment of CNV or advanced AMD in the study eye, except for dietary supplements or vitamins
  • Any intraocular or ocular surface surgery (including cataract surgery and laser procedures) in the study eye within 3 months
  • Vitrectomy in the study eye
  • Hereditary or chronic hemorrhagic or coagulopathy conditions (i.e., hemophilia)

Treatment and study plan

hI-con1

Biological

Intravitreal injection of hI-con1 0.3 mg

Other names: human Immuno-conjugate 1

ranibizumab

Biological

Intravitreal injection of ranibizumab 0.5 mg

Other names: Lucentis®

Sham Injection

Other

No injection is given, a needleless syringe is used to mimic an injection.

Primary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Month 3

    Time frame: Baseline and Month 3

    Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.

  2. Change From Baseline in Central Retinal Subfield Thickness (CST) in the Study Eye at Month 3

    Time frame: Baseline and Month 3

    Optical Coherence Tomography (OCT) imaging was performed pre treatment during visits in which study treatment was administered and to assess lesion characteristics for the study eye. and were evaluated by a central reading center for standardized grading.

Secondary outcomes

  1. Change From Baseline in BCVA in the Study Eye at Month 6

    Time frame: Baseline and Month 6

    Best corrected visual acuity (BCVA) was measured pre treatment prior to dilating eyes, using standard Early Treatment Diabetic Retinopathy Study (ETDRS) retro illuminated charts. The BCVA was recorded as the total letter score in each eye.

  2. Change From Baseline in CST in the Study Eye at Month 6

    Time frame: Baseline and Month 6

    Central Retinal Subfield Thickness (CST) as measured by Optical Coherence Tomography (OCT). The change from the baseline measurement was compared to the month 6 measurement.

Sponsors and collaborators

Lead sponsor

Iconic Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2 Randomized, Double-masked, Multicenter, Active-controlled Study Evaluating Administration of Repeated Intravitreal Doses of hI-con1™ in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Acronym: EMERGE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2015
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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